Actively Recruiting
A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
Led by Hospital Alemão Oswaldo Cruz · Updated on 2025-07-31
90
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
H
Hospital Alemão Oswaldo Cruz
Lead Sponsor
U
University College, London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a culturally adapted Brazilian version of the START program, called ESCADA, designed to help family caregivers of people living with dementia. This controlled trial is conducted within the Brazilian Unified Health System (SUS) across 10 municipalities, aiming to assess how well the program can be delivered and accepted, as well as its impact on caregiver burden, mental health, and quality of life. The study involves trained community general health workers (CGHW) who will provide the intervention. The intervention consists of eight weekly, individualized, home-based sessions led by trained CGHW. The program covers coping strategies, behavior management, and communication skills, supported by printed materials and structured exercises for caregivers. CGHW receive a 16-hour in-person training and ongoing remote supervision during the intervention. Ten municipalities with suitable primary care units (PCU) are randomly assigned to either receive the intervention or be in a waitlist control group, with control participants offered the program after six months. Participants' involvement includes assessments at baseline and approximately six months after the intervention. Researchers will measure feasibility through questionnaires, operational metrics, and qualitative interviews about the intervention's acceptability and adherence. Secondary outcomes such as caregiver burden, anxiety and depression, quality of life, coping strategies, and neuropsychiatric symptoms of the care recipient will also be evaluated. Intervention fidelity is monitored by reviewing session recordings and checklists. The total follow-up period is six months post-baseline.
CONDITIONS
Brief Title
Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informal caregivers aged 18 years or older who are primary or one of the primary persons responsible for caring for a family member with dementia
- Caregivers provide regular and sustained emotional or practical support every week
- Caregivers live in the same household or nearby with frequent face-to-face interaction
- Care recipient has a Clinical Dementia Rating (CDR) score of 1 or higher
- Care recipient has at least one ICD-10 dementia diagnosis code documented in their medical record
You will not qualify if you...
- Caregivers who are illiterate
- Caregivers who provide only occasional or sporadic support (less than weekly or without regular caregiving responsibility)
- Care recipients who are institutionalized, such as living in long-term care facilities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive eight individualized, weekly, home-based sessions of the START intervention delivered by trained community general health workers. These sessions include coping strategies, behavior management, and communication skills, supported by printed materials and structured exercises.
Weekly home visits for 8 weeks
Duration - 6 months post-baseline
Participants complete assessments to measure caregiver burden, mental health symptoms, quality of life, coping strategies, and neuropsychiatric symptoms of the care recipient six months after baseline.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Lucas Martins Teixeira
Vitória, Espírito Santo, Brazil
Actively Recruiting
Research Team
L
Lucas Martins Teixeira
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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